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Proposed Collection; Comment Request; Women's Health Initiative Observational Study

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Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, Office of the Director, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection: Title: Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB #0925-0414 Exp: 04/06. Need for Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: On occasion. Affected Public: Individuals and physicians. Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is as follows:

Type of respondentsEstimated number of respondentsEstimated number of responses per respondentAverage burden hours per responseEstimated total annual burden hours requested
OS Participants85,7861.2118,195
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Physician's Office Staff41.0835.33

The annualized cost burden to respondents is $290,230. There are no annual Capital Costs, Operating Costs and/or Maintenance Costs to report.

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

For Further Information Contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Linda Pottern, Project Officer, Women's Health Initiative Program Office, National Institutes of Health, 6701 Rockledge Drive, 2 Rockledge Centre, Suite 8204, MSC 7935, Bethesda, MD 20892-7935, or call 301-402-2900 or E-mail your request, including your address to:

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication.

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Dated: October 28, 2005.

Jacques Rossouw,

NHLBI, WHI Project Officer, National Institutes of Health.

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[FR Doc. 05-22078 Filed 11-4-05; 8:45 am]